To ensure highest sensitivity, artus CMV Kits have been optimized to detect low numbers of CMV DNA. The analytical sensitivity of the artus CMV QS-RGQ Kit is 42.5 copies/ml in consideration of the purification from EDTA plasma and assay setup using the QIAsymphony RGQ (see figure "Highly sensitive detection of CMV DNA"). (1.00 copies/ml corresponds to 1.64 IU/ml for detection of CMV DNA in EDTA plasma on the Rotor-Gene Q in combination with automated sample preparation and assay setup using the QIAsymphony RGQ. The conversion factor was determined by a regression analysis of multiple dilution series of the 1st WHO International Standard compared against a reference method reporting in IU/ml.)

artus CMV Kits are based on the amplification and simultaneous detection of a specific region of the CMV genome using real-time PCR. The kits provide high levels of specificity, sensitivity (see figure "Highly sensitive detection of CMV DNA"), and reproducibility.

Each artus CMV Kit provides 4 CMV quantitation standards (see figure "Reliable quantitation of CMV load"). Use of the standards enables accurate quantitation of viral load. In addition, the kits contain a second heterologous amplification system to identify possible PCR inhibition. This is detected as an internal control (IC) in a different fluorescence channel from the analytical PCR. The detection limit of the analytical CMV PCR is not reduced.

Specifications of artus CMV RG PCR Kit and artus CMV QS-RGQ Kit

Kit

artus CMV RG PCR Kit

artus CMV QS-RGQ Kit

Validated sample type

EDTA plasma

EDTA plasma or whole blood

Amplicon

105 bp region of the major immediate early (MIE) gene

105 bp region of the major immediate early (MIE) gene

Procedure

artus CMV PCR Kits provide all necessary reagents optimized for reliable CMV DNA detection and quantitation. Simply add template DNA to the ready-to-use PCR master mix and Mg solution, and start the reaction on the appropriate real-time cycler using the optimized cycling program described in the kit handbook.

Common temperature profiles for multiple assays in one run

The temperature profile of artus CMV RG PCR Kit and the artus CMV QS-RGQ Kit corresponds to the profiles of the artus RG PCR Kits and artus QS-RGQ Kits for BK virus, EBV, HSV-1/2, and VZV. Therefore, these PCR assays can be performed and analyzed in a single run.

Complete automated system from sample to CMV detection

The QIAsymphony RGQ workflow solution for CMV detection comprises the QIAsymphony SP for sample preparation, the QIAsymphony AS for assay setup, and the artus CMV QS-RGQ Kit on the Rotor-Gene Q. The system enables reliable pathogen detection with a complete CE-IVD-compliant workflow (see figure "Integrated QIAsymphony RGQ system for CMV detection").

Recommendations for viral DNA purification when using the artus CMV LC, RG, or TM PCR Kits

The artus TM PCR Kit is validated for use with the QIAamp DSP Virus Kit. With the artus CMV RG and LC PCR Kits, either the QIAamp DSP Virus Kit or the EZ1 DSP Virus Kit can be used. The artus CMV RG PCR Kit is also available as CE-IVD-marked EASYartus CMV RG PCR Kits, which include the EZ1 DSP Virus Kit for automated viral nucleic acid purification.

Applications

artus CMV RG, LC, and TM PCR Kits enable rapid and sensitive detection of CMV DNA from EDTA plasma with highly accurate quantification. Kits are available for use on the ABI PRISM 7000, 7700, and 7900HT SDS, on the LightCycler 1.1/1.2/1.5/2.0 Instruments, or on Rotor-Gene Q instruments.

The artus CMV QS-RGQ Kit is validated for use with EDTA plasma or whole blood and is designed to be used with the QIAsymphony RGQ system, providing a complete CE-IVD-compliant workflow from sample to CMV DNA detection and quantitation.